CHANGE HEALTHCARE CANADA COMPANY: Device Recall

Recall Details

Recall Number

Z-2072-2025

Classification

Class II

Product Type

Device

Recalling Firm

CHANGE HEALTHCARE CANADA COMPANY

Status

Ongoing

Date Initiated

05/22/2025

Location

Richmond, Canada

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

4 systems

Reason for Recall

Due to complaints, software update may cause software to unexpectedly shutdown.

Product Description

Change Healthcare Cardiology Hemodynamics Software

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.

Other Recalls by CHANGE HEALTHCARE CANADA COMPANY

• Class II: Risk 08/13/2025
  Due to software issue, radiology reports may not be fully displayed when viewing.
• Class II: Risk 05/22/2025
  Due to complaints, software update may cause software to unexpectedly shutdown.
• Class II: Risk 08/21/2024
  A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
• Class II: Risk 08/21/2024
  A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
• Class II: Risk 08/21/2024
  A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.

View all recalls by CHANGE HEALTHCARE CANADA COMPANY →